The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Multiple Myeloma.
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Koningin Wilhelmina Fonds (KWF)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Event free survival (i.e., time from registration to induction failure, progression or death, whichever occurs first); the time to failure of patients with induction failure is set at one day. <br>
Patients are considered induction failure when they have not achieved at least a PR and are not eligible for further treatment according to protocol.
Achtergrond van het onderzoek
Study phase:
Phase III
Study objectives:
Evaluation of the effect of Thalidomide in addition to AD and High Dose Melphalan.
Patient population:
Patients with multiple myeloma, previously untreated, Salmon & Durie stage II or III, age 18-65 years inclusive.
Study design:
Prospective, multicenter, randomized.
Duration of treatment:
Expected duration of induction, stem cell collection and intensification (with or without Thalidomide) is 5 - 7 months.
Thalidomide will be continued as maintenance until relapse or progression; however it will be discontinued early when the patient has not at least a PR 3 months after Melphalan. In patients not randomized to Thalidomide, maintenance therapy with a-Interferon will be given until relapse or progression.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients with multiple myeloma, meeting all eligibility criteria will be randomized on entry between:
Arm A:
standard Vincristine, Adriamycin and Dexamethasone (VAD) induction, followed by intensive chemotherapy with High-dose Melphalan, followed by maintenance therapy with alpha-interferon.
Arm B:
induction chemotherapy with Thalidomide, Adriamycin and Dexamethasone (TAD) followed by intensive chemotherapy with High-dose Melphalan, followed by maintenance with Thalidomide.
Publiek
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Wetenschappelijk
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
2. Age 18-65 years inclusive;
3. WHO performance status 0-3;
4. Negative pregnancy test at inclusion if applicable;
5. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known intolerance of Thalidomide;
2. Systemic AL amyloidosis;
3. Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;
4. Severe cardiac dysfunction (NYHA classification II-IV);
5. Significant hepatic dysfunction (serum bilirubin >= 30 micromol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
6. Patients known to be HIV-positive;
7. Patients with active, uncontrolled infections;
8. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
9. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
10. Patients <= 55 years with an HLA-identical sibling who will undergo myeloablative AlloSCT.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL201 |
| NTR-old | NTR238 |
| Ander register | : HO50 |
| ISRCTN | ISRCTN06413384 |
Samenvatting resultaten
<br><br>
2 voorafgaande onderzoeken: <br>
<br><br>
M.C. Minnema, I. Breitkreutz, J.J. Auwerda, B. van der Holt, F.W. Cremer, A.M. van Marion, P.H. Westveer, P. Sonneveld, H. Goldschmidt and H.M. Lokhorst. Prevention of venous thromboembolism with low molecular-weight heparin in patients with multiple myeloma treated with thalidomide and chemotherapy. Leukemia, 18(12), 2044-2046. 2004<br><br>
H. Goldschmidt, P. Sonneveld, F.W. Cremer, B. van der Holt, P. Westveer, I. Breitkreutz, A. Benner, A. Glasmacher, I.G.D. Schmidt-Wolf, H. Martin, D. Hoelzer, A.D. Ho and H.M. Lokhorst. Joint HOVON-50/ GMMG-HD3 randomized trial on the effect of thalidomide as part of a high-dose therapy regimen and as maintenance treatment for newly diagnosed myeloma patients. Annals of Hematology, 82, 654-659. 2003